Monitoring drug performance with the power of technology
The humankind reached a high level of the technological development. We even plan to send humans to Mars in several decades.
We found remedies to such cruel diseases as smallpox that used to be one of the most feared diseases given its high incidence and infectious nature. We use latest technological breakthroughs like 3D printing to create new organs and tissues. Still, people continue to suffer from other diseases and medical conditions like obesity, cancer, diabetes mellitus (aka diabetes) and arthritis, to name a few.
Pharmaceutical companies work on developing new drugs to combat existing health problems. Dozens of drugs get approval each year. FDA, for instance, approved 45 drugs in 2015.
However, successful clinical trials and an approval do not mean that drugs will be as good as they are believed to be: they can have some unexpected (and relatively common) side effects like rashes, a weight gain, and more.
Undiscovered before the product launch, these unforeseen risks may deprive the drug of the supposed-to-be success. The first six months after the product is launched are a period on which much of the product success depends on, and pharmaceutical companies must take active measures to ensure that their product has the right trajectory.
Pharmaceutical companies must be quick on the uptake to understand changes they should make in their marketing strategies or in the product itself to outstrip competitors. Yet, it should be noted that the competition has become so fierce recently.
Pharmaceutical companies lacked real-time data and their commercial models were not flexible enough to track the performance of a product and make any course corrections. What is more, the success of a new product did not depend on the rapid adjustment of their launch plans.
Importance of Real-Time Data to Healthcare Players
Nowadays the healthcare environment is dynamic and diverse. This makes a product launch a much more complex process than it used to be several decades ago.
With many new drugs being under development and new companies entering the marketplace, companies already present in the pharmaceutical market need to make use of real-time insights and quickly react to changes occurring in the healthcare domain.
A volume of pharma-related data continues to increase and this growth improves the ability of the pharmaceutical industry to address the growing market complexity.
Healthcare players can gather information they need from different sources: claims, social media, clinical data, etc.
Launch teams have a rough time after a product launch, and a lack of accurate information that can be delivered on time are something that most of such teams are missing. The teams spend much time preparing a launch plan and making it perfect, but they fail to make any adjustments when the launch took place and lose opportunities that could be grabbed.
Access to timely and precise information is also very important if we speak about the clinical context. Hospital staff usually pay much attention to adverse events (AEs) that are reported to their incident reporting systems and use such reports to conduct patient safety improvement activities. But according to the study, guidance of the accidents remain unreported.
But healthcare organizations and pharmaceutical companies can get information about AEs from the government, but there is another challenge: governments release the reports not very often - one or several times per a year.
This gap has been in place for many decades. Modern technologies can eliminate it by making use of information found on the Internet. This information can be used to monitor the pharmacovigilance compliance.
Regulatory authorities now understand how important it is to listen to the voice of patients. They are increasingly interested in acquiring drug-related data (e.g. data on AEs) from different sources like regulatory agencies, social media, clinical electronic health reports, etc.
Social Media as a Source of Pharmaceutical Information
Social media networks are one of the sources where real-time pharmaceutical information can be obtained directly from patients. The number of their users has increased significantly over the last few years. For instance, Twitter had 313 million monthly active users in mid-2016.
Patients post information on drugs they take in social media (e.g. Facebook and Twitter). Specialized healthcare- and pharma-related networks like MedHelp and PatientsLikeMe are also very popular. Patients can discuss their health problems, share drug-related experience and give advice to each other there. The fact that patients suffer from similar diseases and medical conditions makes these platforms a collection of valuable patient views on drug performance.
Many users report about AEs and side effects in social media using different hashtags (e.g. #accutaneprobz) to pay attention of different agencies and pharmaceutical manufacturers.
People tend to create different product ratings and share their reviews of different products (e.g. the Doctor Strange movie) with others. Others read these commentaries and decide whether they need these products or not. This approach can be applied to pharmaceutical products, too.
Official bodies have already started to make use of data obtained from social media sources. ABPI (the UK), for instance, issued the guidance to suggest best practices for the monitoring and management of AEs and product complaints from digital media use in company sponsored/non-company sponsored digital media.
When real-time data is particularly important? Such data can play a crucial role when it comes to the development of drugs for the treatment of newly discovered viral or infectious diseases and it is a life-or-deaths issue.
Steps Towards Acquiring Patient-Generated Data
Some steps to start exploiting user-generated data have already been taken. Pharmaceutical companies collaborate with IT companies to create web-based and mobile applications to help medical players, their sponsors and agencies to listen to the voice of patients and consumers directly and in a real-time manner.
US MedWatcher created in collaboration with FDA is one the latest solutions. Such tools (like the one we dealt with) offer insights into how drugs perform and how they affect people during clinical development and after a product launch took place. They make use of multiple real-world sources, such as regulatory agencies, clinical electronic health records, and social media.
The pharmaceutical market becomes increasingly commercial. The need to address a large number of diseases and medical conditions is unlikely to be solved soon. So the competition between existing pharmaceutical companies and newcomers will become increasingly intense.
The players must understand that they can enjoy access to real-time data since this information will enable them to adjust their marketing strategies, learn AEs their products or similar drugs have, keep abreast of the latest changes in the regulatory landscape, and more. They can use solutions created by custom healthcare solutions developers or ask an IT company to develop a custom tool.
About the Author
Tatsiana Levdikova is a Tech/IT Journalist at EffectiveSoft, a custom software development company with 250+ specialists who boast expertise in different business domains
The views, opinions and positions expressed within these guest posts are those of the author alone and do not represent those of Becker's Hospital Review/Becker's Healthcare. The accuracy, completeness and validity of any statements made within this article are not guaranteed. We accept no liability for any errors, omissions or representations. The copyright of this content belongs to the author and any liability with regards to infringement of intellectual property rights remains with them.
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